Silver Nanoparticle Investigation for Treating Chronic Sinusitis

Phase 1

Withdrawn

• Conditions: Chronic Rhinosinusitis (Diagnosis)
• Interventions: Drug: Colloidal silver nanoparticles; Other: Purified Water

• Registration Number: NCT03243201
• Lead Sponsor: Washington University School of Medicine

Brief Summary

Chronic rhinosinusitis is a highly prevalent disease resulting in high economic burden. Effective therapeutic options are needed. Rhinosinusitis-related biofilms are a likely contributor to recalcitrant disease. Emerging evidence shows that colloidal silver nanoparticles may be effective for reducing biofilms. The investigators intend to perform a randomized, double-blinded, placebo-controlled clinical trial to evaluate the effectiveness and safety of intranasal colloidal silver nanoparticles in adult patients with chronic rhinosinusitis. The investigators hypothesize that compared to placebo, treatment with intranasal colloidal silver for chronic rhinosinusitis will lead to a significant improvement in symptom scores and will not be associated with increased rate of adverse effects.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-04
• Study First Submitted QC: 2017-08-07
• Study First Posted: 2017-08-08
• Study Start: 2018-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-11
• Primary Completion: 2018-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Twelve (12) weeks or longer of two or more of the following signs and symptom consistent with chronic rhinosinusitis (CRS):

• mucopurulent drainage (anterior, posterior, or both), nasal obstruction (congestion), facial pain-pressure-fullness, or decreased sense of smell

AND inflammation is documented by one or more of the following findings:

• purulent (not clear) mucus or edema in the middle meatus or ethmoid region
• polyps in nasal cavity or the middle meatus
• and/or radiographic imaging showing inflammation of the paranasal sinuses

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Exclusion Criteria

• Unable to speak English
• History of nasal or sinus surgery within past 6 weeks
• History of comorbid ciliary dyskinesia, cystic fibrosis or any other mucociliary condition
• Dependence on prolonged corticosteroid therapy for comorbid condition
• History of renal impairment
• History of cerebrospinal fluid leak

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colloidal Silver	Colloidal silver nanoparticles	The colloidal silver arm will administer intranasal colloidal silver, 2 sprays each nostril twice daily, for a total volume of 0.8ml per day (8 mcg of silver per day), for 28 days.
Purified Water	Purified Water	The placebo arm will administer intranasal purified water, 2 sprays each nostril twice daily, for a total volume of 0.8ml per day, for 28 days.

Primary Outcome Measures

Name	Time	Method
Sino-Nasal Outcome Test (SNOT-22)	Four weeks	Assess change in SNOT-22 score